Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

JOH · Predicate Candidate Screening

109 FDA 510(k) clearances under this product code; the 50 most recent screened below.

118 daysmedian FDA review time

282 days90th percentile

109clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251313	Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard	Covidien, LLC	2025-12-29	245	0
K210833	Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionai	Smiths Medical Asd, Inc.	2021-11-26	252	0
K203362	TRACOE vario	Tracoe Medical GmbH	2021-08-05	262	0
K193077	Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard	Covidien	2020-06-01	209	0
K193133	Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set	Cook Incorporated	2019-12-12	30	4
K182861	Shiley Neonatal/Pediatric Tracheostomy Tube	Covidien	2019-03-22	162	0
K173912	BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselec	Smiths Medical Asd, Inc.	2018-05-08	137	1
K180034	Weinmann Tracheostomy Exchange Set	Cook Incorporated	2018-05-07	123	0
K172720	TRACOE silcosoft Tracheostomy Tube	Tracoe Medical GmbH	2018-04-27	231	0
K170720	Portex Blue Line Ultra Paediatric Tracheosomy Tube	Smiths Medical Asd, Inc.	2017-12-07	273	0
K151404	ProTrach Dualcare	Atos Medical AB	2016-02-12	262	0
K150844	Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable I	Covidien	2015-07-14	106	2
K142296	Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable	Covidien	2015-02-24	190	1
K142298	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tub	Covidien	2015-02-13	179	1
K133528	H&H EMERGENCY CRICOTHYROTOMY KIT	H & H Medical Corporation	2014-07-03	230	0
K133173	RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET	Teleflexmedical, Inc.	2014-05-23	218	0
K133597	CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGL	Cook, Inc.	2014-04-18	147	1
K122932	SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE W	Fogless International AB	2013-12-23	455	0
K122235	RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET	Teleflexmedical, Inc.	2013-09-06	407	0
K123699	FAHL TRACHEOSTOMY TUBES (MULTIPLE)	Andreas Fahl Medizintechnik-Vertrieb GmbH	2013-08-12	252	0
K122531	SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC	Covidien	2012-10-09	50	1
K100995	SHIKANI SPEAKING VALVE	Shikani Medical, LLC	2010-06-25	77	0
K093469	CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRO	Cook, Inc.	2010-01-08	63	17
K083641	BIVONA TRACHEOSTOMY TUBES	Smiths Medical Asd, Inc.	2009-02-23	76	1
K081440	BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOM	Smiths Medical Asd, Inc.	2008-09-12	113	0
K072582	PROVOX MICRON HME	Atos Medical AB	2008-05-30	260	0
K072148	CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY	Cook, Inc.	2007-10-03	61	0
K051416	SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND	Mallinckrodt Medical	2005-06-16	15	0
K043160	TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PH	Tracoe Medical GmbH	2005-02-18	95	0
K041485	MARPAC MESSENGER MODEL #501	Marpac, Inc.	2004-08-02	59	0
K041044	CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET	Cook, Inc.	2004-07-29	98	0
K041348	PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH	Smiths Medical	2004-07-13	54	0
K040014	PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DIL	Portex , Ltd.	2004-02-13	51	0
K030787	SHILEY FLEXTRA TRACHEOSTOMY TUBE	Nellcor Puritan Bennett, Inc.	2003-11-14	247	1
K031057	PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT	Portex, Inc.	2003-07-18	106	7
K023918	RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS	Rusch Intl.	2003-03-28	123	2
K022212	PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS	Mentor Medical Limited	2003-03-21	256	0
K013728	TRACH VOX	Engineered Medical Systems	2002-07-30	263	0
K014102	PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251	Atos Medical AB	2002-02-21	70	0
K011210	THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY	Rusch Intl.	2001-08-15	118	0
K003315	SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND	Mallinckrodt, Inc.	2000-11-08	16	1
K000964	STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109	Automatic Liquid Packaging, Inc.	2000-04-25	29	0
K990905	PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020	Passy-Muir, Inc.	1999-06-11	85	0
K970811	DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DIS	Pneumocare, Inc.	1998-11-13	618	0
K982128	SHIKANI-FRENCH SPEAKING VALVE	Pilling Weck Surgical	1998-10-23	128	0
K972546	RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET	Rusch Intl.	1998-04-14	280	0
K980466	PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIA	Sims Portex, Inc.	1998-02-24	18	1
K973829	IRRIGATION BOTTLE	Automatic Liquid Packaging, Inc.	1998-02-23	139	0
K972423	RUSCH TRACHEOFIX-SET	Rusch Intl.	1998-02-13	231	0
K972385	FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED	Smiths Industries Medical Systems, Inc.	1998-01-20	208	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda